MAUDE Adverse Event Report: RANIR LLC KROGER MTH GD RST ASRD W/TRAY; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD RST ASRD W/TRAY 2CT CD

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

Consumer stated the dental guard lasted about a month but it started splitting and chipping away in the front.Received product 8.28.19.

• Brand Name: KROGER MTH GD RST ASRD W/TRAY
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 4343
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 4343
• Manufacturer Contact: brenda mumbower ; 4701 east paris ave se; grand rapids, MI 49512-4343 ; 6166988880
• MDR Report Key: 9009727
• MDR Text Key: 167641006
• Report Number: 1825660-2019-00614
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Distributor Facility Aware Date: 08/19/2019
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1